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Details for Patent: 5,840,857

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Details for Patent: 5,840,857

Title: Urinary follicle stimulating hormone
Abstract:Purification of human FSH from post-menopausal urine gonadogropin using immunochromatography and reverse phase HPLC steps yelds a biologically active hormone which is free from detectable traces of LH and other urinary proteins.
Inventor(s): Arpaia; Guiseppe (Rome, IT), Serani; Serenella (Rome, IT), Sirna; Antonino (Rome, IT), Villa; Stefano (Rome, IT)
Assignee: Istituto di Ricerca Cesare Serono S.p.A. (Rome, IT)
Filing Date:Dec 29, 1995
Application Number:08/580,858
Claims:1. A process for preparing a substantially pure biologically active follicle stimulating hormone (FSH) preparation, free from traces of luteinizing hormone detectable at 1.5 mIU/ml, based on the 2nd IRP-HMG reference standard for luteinizing hormone, and substantially free from all other urinary proteins, comprising subjecting a post-menopausal urinary concentrate to immunopurification using FSH-specific immobilized monoclonal antibodies to form an immunocomplex of FSH and the antibodies thereto, eluting to recover the FSH, and removing any residual traces of contaminants by reverse phase HPLC.

2. The process of claim 1 wherein the post-menopausal urinary concentrate contains Human Menopausal Gonadotropin.

3. The process of claim 1 wherein elution of FSH from the immunocomplex is carried out using as eluent an aqueous solution having a pH higher than about 10 and a molarity higher than about 0.5.

4. The process of claim 3 wherein the eluent has a pH comprised within the range of 11.3 to 11.7 and a molarity of about 1.

5. The process of claim 4 wherein the eluent is 1M ammonia.
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